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NTC Submits Marketing Authorization Application for KLEERKOL® in EU

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NTC Srl, R&D driven pharmaceutical company with headquarters in Italy announces the submission of the marketing authorization application through the European Decentralised Procedure (DCP) for its development product NTC015 (Kleerkol®) for bowel preparation for colonoscopy.

“Colonoscopy remains the standard for diagnosing and monitoring colorectal cancer and for diagnosis and surveillance of inflammatory bowel disease”, says Maurizio Vecchi, Gastroenterology and Endoscopy Unit, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy. “The colon must be completely emptied from stool for the procedure. All patients currently must undergo a scheduled bowel preparation, sometimes lasting more than one day, which includes dietary restrictions, and ingesting large amounts of fluid and solutions for colon cleansing. An effective drug favoring a quick bowel cleaning, palatable and easy to be taken by patients would represent a new and attractive therapeutic option.”

“Often bowel preparation before a colonoscopy is experienced as burdensome and, if inadequate, it leads to suboptimal effectiveness, increasing the need to repeat the procedure. Indeed, some patients decide not to undergo the test because of disturbing bowel preparation” Peter Uebel, Practice for gastroenterology and specialist internal medicine in the House of Health, Ludwigshafen am Rhein, Germany states. “For this reason, it is important to offer patients an effective, easy-to-use, fast-acting, simpler and palatable preparation.”

NTC015 was developed to respond to the unmet medical needs of being quick, easy to take, and good tasting. For its approval, a controlled trial with an adaptive study design was conducted. “We have recently concluded the Satisfaction Trial, a large multicentre international study on Kleerkol®. Based on the study outcome, we submitted the marketing authorisation application in the EU. Our goal is to make Kleerkol® available in Europe as soon as possible. We are also expecting to register it beyond Europe, on a global basis, in collaboration with our partners. Today, we have several countries still available for partnering, to offer to patients and doctors this innovative solution all over the world” Riccardo Carbucicchio, Chief Executive Officer of NTC concludes.

A pharmaceutical company headquartered in MilanItaly, with distributors and partners in more than 100 countries, engaged in research, development, registration, and commercialization of drugs, medical devices, and food supplements in ophthalmology, and in other therapeutic areas including pediatrics, gynecology, and gastroenterology. NTC offers to more than 200 partners innovative and high-quality standard pharmaceutical products.

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